DeviceClearance

Product code OUB— General, Plastic Surgery

MIRADRY SYSTEM

Classification name
Instrument For Treatment Of Hyperhidrosis
Device class
Class 2
Regulation
21 CFR 878.4400
Advisory panel
General, Plastic Surgery
Total cleared
3
First cleared
Most recent

FDA classification definition

“Soft-tissue coagulation”

— U.S. Food and Drug Administration, device classification record for product code OUB under 21 CFR 878.4400, via openFDA

Market context for product code OUB

FDA has cleared 3 devices under product code OUB between 2011 and 2015, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code OUB

Adverse events under product code OUB

product code OUB
Injury
215
Total
215

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code OUB

Data sourced from openFDA. This site is unofficial and independent of the FDA.